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Wednesday, February 27, 2013

J&J Expert Says Infection, Not Defect, Led to Hip Failure

Bloomberg

By Maurice Possley and David Voreacos on February 26, 2013

A witness for Johnson & Johnson (JNJ)
testified that an infection led a Montana man to have his metal-
on-metal hip device replaced, not a defect in the prosthesis.

Gonzalo Ballon-Landa, an infectious diseases doctor,
testified today at a Los Angeles trial on a lawsuit by Loren
Kransky. He claims J&J defectively designed his ASR hip device
and failed to warn of risks. The lawsuit is the first of 10,000
to go to trial. Analysts say J&J may pay billions of dollars to
resolve cases over the ASR, which the company recalled in 2010.

J&J, the world’s largest seller of health-care products,
called Ballon-Landa to counter Kransky’s claim that the hip
failed because of a defective design. Rather, Ballon-Landa said,
Kransky had so-called revision surgery to replace his ASR
because of an infection that spanned several years, he said.
“The infection caused him pain, and the pain is why Mr.
Kransky had revision surgery,” Ballon-Landa told state court
jurors. He said the kind of infection Kransky had was “the most
common cause of artificial joint infections.”

Kransky, a 65-year-old former prison guard, had the hip
implanted in December 2007 and removed in February 2012. Ballon-
Landa said he developed a staph infection through the port used
to administer chemotherapy drugs for his kidney cancer.

He pointed to a 2009 medical report in which Kransky
complained of pain in his hip. Kransky’s doctor described a lump
as swelling. Ballon-Landa said the infection was present from
2009 until Kransky had his hip replaced.

‘Infected Hip’

“It is impossible to completely cure an infected hip,” he
said.

J&J’s DePuy unit recalled the hips when their failure rate
hit 12 percent in the U.K. Since then, the failure rate hit 40
percent in Australia. J&J, based in New Brunswick, New Jersey,
denies that it defectively designed the device or failed to warn
of the risks.

On cross-examination by Kransky attorney Michael Kelly,
Ballon-Landa said none of the five physicians who examined
Kransky from December 2007 until his revision found an
infection.
“There’s no indication that they thought he had an
infection,” Ballon-Landa said.

Showed Symptoms

Kelly also displayed a medical journal article about
patients with metal-on-metal hip revisions that showed symptoms
that “mimicked a deep-seated hip infection,” although they
actually had none.
Kranksy’s lawyers have said the device, made of chromium
and cobalt, shed metal ions into the tissue and bloodstream of
patients.

J&J attorney Alexander Calfo said Kransky’s claim of
elevated metal levels in his body can be traced to conditions
including diabetes, high blood pressure and cholesterol, strokes
and kidney cancer. Kransky, Calfo said, is a vasculopath, which
means he has diseased blood vessels throughout his entire body.

Another J&J witness, John Cuckler, a retired orthopedic
surgeon, also testified that Kransky’s hip was infected.

Cuckler, who performed about 5,000 total hip surgeries,
including 2,400 revisions, said the ASR wasn’t defective. He
also said Kransky’s buildup of metal debris around his hip was
caused by an infection and the steep angle at which his surgeon
implanted his device. Surgeons place the cup in the hip and a
ball atop the femur. The ball rotates in the cup.

Based on his experience as a developer for a competing
metal-on-metal hip made by Biomet Inc. and his review of the ASR
design file, Cuckler said. “I think this is a safe design which
is not defective in any way.”

‘Spot On’

He said the testing that DePuy performed on the ASR “was
absolutely spot on” with industry standards in 2000 when the
tests were performed. Testing has become more sophisticated over
the past decade, “but it was appropriate for the standards at
the time,” he said.

“We can never fully recreate the demands placed on the
human body with a machine,” Cuckler said. “There is no
simulator test that has ever fully approximated the performance
of a device in a human being.”

Cuckler said DePuy paid him $500,000 to analyze the ASR.

“I was astounded at how much testing they did and was
done,” he said. “I’ve never seen an implant as thoroughly
tested.”

Jurors, who began hearing the case on Jan. 25, are expected
to hear closing arguments on Feb. 28.
The case is Kransky v. DePuy, BC456086, California Superior
Court, Los Angeles County (Los Angeles).

To contact the reporters on this story:
Maurice Possley in Los Angeles Superior Court at
mauricepossley@gmail.com;
David Voreacos in Newark, New Jersey, at
dvoreacos@bloomberg.net.
To contact the editor responsible for this story:
Michael Hytha at mhytha@bloomberg.net.